SILKA ANTIFUNGAL- tolnaftate liquid

Silka Antifungal by

Drug Labeling and Warnings

Silka Antifungal by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

• For effective treatment of most athlete's foot and ringworm
• Relieves itching, scaling, cracking, burning, redness, soreness, irritation and discomfort. Helps prevent most athlete's foot (dermatophytosis) with daily use.

Warnings

For external use only

• Do not use on children under 2 years of age unless directed by a doctor.

When using this product avoid contact with the eyes.

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks (for athlete's foot and ringworm).

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• This product is not effective on the scalp or nails. For athlete's foot and ringworm: use daily for 4 weeks. Clean the affected area and dry thoroughly
• Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
• Supervise children in the use of this product
• For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
• To prevent athlete's foot, apply once or twice daily (morning and/or night)
• Apply to skin around the nail and cuticle.

Other information

• Store at room temperature 15° – 30°C (59° -86°F)

Inactive ingredients

Aloe Barbadensis Leaf Extract, BHT, Carthamus Tinctorius (Safflower) Seed Oil, Hydrogenated Polyisobutene, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Oryza Sativa (Rice) Bran Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate.

Questions or comments?

Call toll free 1-877-994-3666

Monday to Friday, 8 am to 6 pm Central time.

SPL UNCLASSIFIED SECTION

Distributed by:
Genomma Lab., Houston, TX 77027

PRINCIPAL DISPLAY PANEL - 13 ML Bottle Carton

SILKA®

MAX STRENGTH

ANTIFUNGAL
LIQUID

• » KILLS
  FUNGUS
• » STOPS ITCHING
  AND BURNING
• » HELPS RESTORE
  SKIN HEALTH

BEFORE
AFTER
DRAMATIZATION

WITH BRUSH
APPLICATOR

CLINICALLY PROVEN
AGAINST ATHLETE'S
FOOT FUNGUS

0.45 FL OZ / 13 ML

INGREDIENTS AND APPEARANCE

SILKA ANTIFUNGAL 
tolnaftate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-083
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV)	Tolnaftate	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SAFFLOWER OIL (UNII: 65UEH262IS)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
LAVENDER OIL (UNII: ZBP1YXW0H8)
TEA TREE OIL (UNII: VIF565UC2G)
RICE BRAN OIL (UNII: LZO6K1506A)
SESAME OIL (UNII: QX10HYY4QV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-083-01	1 in 1 CARTON	03/22/2022
1		13 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	03/22/2022

Labeler - Genomma Lab USA (832323534)